Device Dossier

Straumann Membrane Flex - Collagen dental regeneration membrane

Device Dossier for Straumann Membrane Flex - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor Straumann).…

Intended purpose

A sterile bioresorbable, implantable collagen material, that is intended for use in oral surgical procedures, as a resorbable membrane material for use in: • simultaneous use of guided bone regeneration (GBR)-membrane and implants; • augmentation around implants placed in immediate extraction sockets; • augmentation around implants placed in delayed extraction sockets; • localized ridge augmentation for later implantation; • alveolar ridge reconstruction for prosthetic treatment; • filling of bone defects after root resection, cystectomy or removal of retained teeth; • guided bone regeneration in dehiscence defects; and • guided tissue regeneration procedures in periodontal defects.

Functional description

The resorbable porcine collagen dental membrane acts as a barrier membrane for Guided Tissue Regeneration (GTR) or Guided Bone Regeneration (GBR). The membrane contains bone graft material, retards epithelial down growth and prevents gingiva connective cell migration into the wound site.

TGA Public Summary